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Lansoprazole to Treat Children With Asthma

NCT00442013 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 306

Last updated 2012-12-06

Study results available
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Summary

Many individuals with asthma also experience gastroesophageal reflux disease (GERD), a condition in which excess stomach acid flows backwards into the esophagus. This study will evaluate the effectiveness of lansoprazole, a medication commonly used to treat GERD in improving asthma control and reducing symptoms in children with poorly controlled asthma.

Conditions

Interventions

DRUG

Lansoprazole

Participants less than 30 kg will receive 15 mg a day, by mouth; participants greater than or equal to 30 kg will receive 30 mg a day, by mouth.

DRUG

Matching placebo

Participants will receive a placebo pill on a daily basis. To maintain masking, there are two doses of the matching placebo provided to participants depending on participant body weight at randomization: 1.) less than 30kg will receive 15mg po once daily or 2.)greater or equal to 30kg 30mg po once daily.

Sponsors & Collaborators

  • American Lung Association Asthma Clinical Research Centers

    collaborator OTHER

  • National Heart, Lung, and Blood Institute (NHLBI)

    collaborator NIH

  • Johns Hopkins University

    lead OTHER

Principal Investigators

  • Janet Holbrook, PhD, MPH · Johns Hopkins University School of Public Health

  • Gerald Teague, MD · University of Virginia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-03-31
Primary Completion
2011-04-30
Completion
2011-08-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00442013 on ClinicalTrials.gov